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The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

The proposed device is a disposable enteral feeding syringe provided two models, including Type A and Type B, the main difference is the piston of Type A is rubber stopper made of isoprene rubber, and the piston of Type B is rubber pad made of silicone rubber. The proposed device consists of a syringe barrel, syringe plunger and piston (rubber stopper or rubber pad). They are available in 1ml, 3ml, 5ml, 10ml, 20ml, and 60ml. The enteral syringes are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied maintenance package which could maintain the sterility of the device during the shelf life of five years.

This document is a 510(k) premarket notification for an Oral/Enteral Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study of an AI/ML powered device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and study proving an AI/ML device meets those criteria.

The document states:

• "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• "No clinical study is included in this submission."

Therefore, I cannot extract the requested information as it pertains to a medical device (syringe), not an AI/ML powered device.

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